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BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) is a Swedish research-based biopharmaceutical company that focuses on developing innovative treatments to slow or halt the progression of neurodegenerative diseases. Founded by Professor Lars Lannfelt, the company is renowned for its groundbreaking work in Alzheimer's disease, particularly with the development of Leqembi® (lecanemab), the world's first drug proven to slow cognitive decline in early Alzheimer's disease patients.
BioArctic operates through strategic alliances, with a significant partnership with Eisai, a global pharmaceutical company. Together, they developed lecanemab, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody targeting aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab has been granted approval in the U.S., Japan, China, and South Korea, with pending applications in several other countries including the European Union and Canada. The drug's efficacy was demonstrated in the Phase 3 Clarity AD study, which met all primary and key secondary endpoints with statistically significant results.
Recently, BioArctic and Eisai presented new data on lecanemab at the 2024 International Conference on Alzheimer's and Parkinson's Diseases, showcasing its binding properties and lower incidence of adverse events compared to other antibodies. This data reinforces the importance of early diagnosis and treatment in managing Alzheimer's disease.
In addition to Alzheimer's research, BioArctic's portfolio includes antibodies targeting Parkinson's disease and ALS. They employ their proprietary BrainTransporter™ technology, which enhances the delivery of therapeutic antibodies across the blood-brain barrier, potentially increasing the efficacy of treatments.
BioArctic is also committed to sustainable innovation and has integrated environmental, social, and corporate governance principles into its operations, recently earning a place on the Nasdaq OMX Sweden Small Cap 30 ESG Responsibility Index. This recognition underscores the company's dedication to responsible business practices and the positive societal impact of its research and development activities.
Financially, BioArctic benefits from royalty payments related to lecanemab sales and milestone payments tied to regulatory approvals. In the first quarter of 2024, Leqembi generated JPY 2.83 billion in sales, resulting in SEK 18 million in royalties for BioArctic, with projections for significant revenue growth in the coming year.
BioArctic's partner, Eisai, projects Leqembi® sales to reach JPY 56.5 billion (approx. SEK 4 billion) for FY 2024 (April 2024 - March 2025), generating SEK 360 million in net royalties for BioArctic. For FY 2023, Leqembi sales were JPY 4.3 billion, resulting in SEK 28.2 million in royalties. BioArctic holds commercialization rights for lecanemab in the Nordic region, pending European approval. The first-quarter report for 2024 will be released on May 17, 2024. The disclosed information complies with the EU Market Abuse Regulation.
Eisai has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. FDA for Leqembi® (lecanemab-irmb) subcutaneous maintenance dosing. This follows the FDA granting Fast Track designation to Leqembi for Alzheimer's disease treatment in early AD stages. Currently approved for biweekly intravenous (IV) treatment, Leqembi's subcutaneous autoinjector simplifies home treatment, reducing the need for hospital visits. The BLA relies on Phase 3 Clarity AD open-label extension study data and aims to maintain effective drug concentrations to sustain clearance of toxic protofibrils. Leqembi is already approved in the US, Japan, and China, with additional applications under review globally. Eisai leads the global development and regulatory submissions, while BioArctic holds commercialization rights in the Nordic region pending European approval.
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